Ethics of new developments in personalised healthcare

A new report released yesterday by the Nuffield Council on Bioethics explores the impact, and ethical consequences, of personalised healthcare in a consumer age.

The report’s remit is incredibly ambitious, covering wide-ranging aspects relating to how people engage, as consumers, with health services online. For example the working party examined ethical dilemmas, benefits and harms involved in accessing health information; online storage of medical records; consumers buying prescription drugs online; “telemedicine” in all its many forms; and the use of “direct to consumer” marketing of gene testing kits and whole body imaging services. The report emphasises the provisional nature of its recommendations and the need for regulatory bodies and the medical profession to monitor future developments.

For many of the areas investigated, the report’s authors conclude that there is not currently enough evidence of possible harm to merit more stringent regulations on services that are offered. For example, in the area of direct-to-consumer genetic testing (as offered by companies such as 23andme ; Navigenics ) it is clear that genetic profiling for variants associated with common polygenic diseases does not have strong clinical validity or utility . A recent article published in PLoS Medicine concluded that, currently, such forms of testing would not satisfy three key criteria for using genomic information in public health screening (the criteria were that the information should predict disease risk better than phenotypic information; that cost-effective interventions should exist for those at increased genetic risk; and that the genetic risk information should motivate the desired behaviour changes).

In the US these tests may be regulated by the FDA as medical devices – requiring evidence of validity and utility. However, the Nuffield report shies away from suggesting such approaches in the UK and concludes that – ‘although there should be restrictions on selling such tests for use in children — providing the companies give out easily understandable information on the evidence, limitations, harms, data privacy, and how the company is run, further regulation is not needed’.

The report does say that the potential for harm associated with direct-to-consumer whole-body imaging (such as CT or MRI scans) may be large, and could be outweighed by any potential benefits. Potential harms include both physical risks (such as increased risk of cancer – particularly with CT scanning) as well as psychological risks (such as anxiety caused by finding minor abnormalities that might otherwise cause no symptoms, or the problems caused by giving the “all clear” when in fact there may be serious pathology). As a result, the report recommends banning companies from offering full-body CT scanning to asymptomatic people (the “worried well”), and states that these types of services should be regulated by relevant national authorities (which at the moment they are not, in the UK).

Throughout the report, the working party emphasised the need for a stronger evidence base of the benefits and harms associated with each intervention. It’s surprising that, for example, the contributors were even unable to find out roughly how many people in the UK had used personal genetic profiling – and it’s also unclear how results of these tests have or might in the future influence individuals’ behaviour. Regrettably, for many of the scenarios discussed in the report, the benefits, harms and ethical dilemmas are only presented as theoretical concerns, with little concrete data around to inform guidance.

About Emma Veitch

Emma Veitch is one of the Senior Editors on PLOS ONE. She blogs (not as frequently as she should!) on publication practices, publication bias and a variety of other topics. She tweets as herself on @veitchemma